In clinical treatment, emphysema is a common pulmonary disease, particularly having a high incidence in the elderly. According to statistics, the survival rate of end-stage emphysema patients who have been sick for 5 years is less than 50 percent. Traditional emphysema medical treatment comprises oxygen inhalation, prevention of pulmonary infection, bronchia spasmolysis, etc. but curative effect is extremely limited. While the surgical treatment of emphysema is given priority to lung volume-reducing surgery, and there are also relatively large amounts of limitations, such as strict indications accompanied with relatively large amounts of complications, anesthesia and complications associated therewith, the curative effect is difficult to predict before surgery, any undesirable curative effect caused by too much or too little removal cannot be compensated after surgery, and the operative cost is high, and mental and physical pain is significant. Additionally, some patients with poor lung function often cannot tolerate the surgeries, therefore possessing high postoperative mortality, which limits the application of surgery.
In order to better treat emphysema, treatment for emphysema is carried out in the intervening modes with bronchoscope researched and utilized internationally, such as a unidirectional valve, xanthan gum, water vapor thermal ablation, and elastic coil for improving the quality of life for patients, and reducing the trauma to patients during surgery. Owing to the fact that the target area residual gas and sputum fails to be discharged effectively and actively, a unidirectional valve has poor clinical index, so the U.S. FDA has not approved this device. Additionally, the effectiveness of unidirectional valve treatment is further restricted by the technical difficulty of collateral ventilation and accurate positioning on different anatomical structures. The problem of postoperative inflammation has also not been adequately solved, due to the fact that the emphysema area is completely blocked by the xanthan gum. In addition, the water vapor is subjected to thermal ablation, which causes postoperative inflammation because of its damage to the original tissue structure of the emphysema area.
Currently, an updated treatment mode is adopted for the treatment of emphysema, that is to say, the elastic coil, as an implant, is implanted into the body pulmonary lesion site. FIG. 1 is a schematic diagram of a lung volume-reducing elastic coil of the prior art. The product is made up of nickel-titanium memory alloy metal wire for design, which can be subjected to elastic deformation under external force. The product, under the constraint of a delivery system, can be implanted into the lung with the bronchoscope working channel in the form of straight strips. After being delivered to the bronchia in the emphysema area, the coil is free from the constraints of the delivery system, recovering its shape to its natural shape (i.e. the shape being free from the external force) as shown in FIG. 1. Meanwhile, the emphysema area is extruded under the traction action of the nickel-titanium alloy wire, the gas in the bronchia is discharged, and the lung tissue volume in the emphysema area is reduced, such that the relatively healthy peripheral lung tissue gives play to better physiological function.
The surgical methods using the elastic coil comprise three operational processes of inserting the bronchoscope, establishing the channel, and implanting the coil. A schematic diagram showing the insertion of the bronchoscope 201 is shown in FIG. 2. A bronchoscope 201 is inserted through the mouth or nose, and an image detected by the distal end 203 of the bronchoscope is displayed on a monitor 204 via the bronchoscope 201, thereby guiding the bronchoscope 201 to reach the human pulmonary bronchia 205.
FIG. 2 also shows the establishment of the channel. The outer diameter of a guidewire 206 is about 5Fr to about 7Fr, while the tube diameter of a delivery sheath can be between about 5Fr and 9Fr. The guide wire 206 is inserted through the inner cavity of a dilator 207 which extends through the inner cavity of a delivery sheath 208, and the guidewire 206, the dilator 207 and the delivery sheath 208 are assembled together to enter the bronchoscope 201 through a working channel 202 of the bronchoscope 201 and to enter the bronchia 205 through the distal end 203 of the bronchoscope 201. A distal end 209 of the guidewire 206 is provided with a length marker 210, which indicates the distance along the guidewire 206 from the distal end 209. A distal end 211 of the delivery sheath 208 can be provided with a plurality of corresponding identifiers 210 in the form of high contrast metal strips (including gold, platinum, tantalum, iridium, tungsten and/or similar metal). The guidewire 206 can be guided using a fluoroscopy system with a remote imaging capture device 212, an ultrasonic imaging system, an MRI system, an X-ray computed tomography (CT) calculating system, or some other remote imaging implants. As shown in FIG. 2, the images detected can be displayed on a monitor 213 by the remote imaging capture device 212, and the track of the guidewire 206 or an imaging marker 210 can be identified by the remote imaging capture device 212, thereby establishing a channel.
After establishing the channel, the dilator 207 and the guidewire 206 are withdrawn from the delivery sheath 208 towards the proximal end, thereby delivering a lung volume-reducing elastic coil 301 in an open cavity of the delivery sheath 208. FIG. 3 is a schematic diagram showing the implanting of the coil 301. A delivery system 302 loaded with the coil 301 is coupled to the proximal end of the delivery sheath 208 by a locking hub connection 303. As shown in FIG. 4, the coil 301 is introduced to the delivering sheath tube, and the coil 301 is pushed out of the distal end of the delivering sheath tube 208 by a wireline 305 of an actuating device 304, thereby entering the bronchia 205. The delivering sheath tube 208 is then withdrawn, and the coil 301 is released by a gripper 306 of the actuating device 304. The coil 301 further pulls the bronchia 205 to curl while the coil 301 recovers into its original shape, thereby achieving the curative effect of reducing the volume of emphysema.
The above implants and the implanting methods thereof have the following shortcomings:
1. The elastic coil made from the prior nickel-titanium wire needs to be released by the delivery sheath, and the inner wall of the bronchia might be injured when the delivery sheath is pushed in the bronchia, causing adverse effects such as pneumothorax.
2. Owing to relatively large outer diameter of the delivery sheath of about 5Fr to 9Fr, it is difficult to implant the elastic coil into the tail end of the lung bypass or each of some small-diameter tracheae via the delivery sheath, and the range of emphysema area pressed and pushed by the elastic coil is limited, thereby affecting the volume-reduction effect.
3. The present surgical method of inserting the elastic coil requires three independently operated processes of inserting the bronchoscope, establishing the channel, and implanting the coils, which takes a long time to complete the procedure. In addition, the procedure is performed when the patient is sober, easily causing adverse events such as COPD acute exacerbation and the like due to the extended procedure time.